Vault Study Startup improves your time to first patient, first visit by managing the process of collecting key documents and completing other activities in the course of starting up a clinical trial. It includes standard document types that support the creation of Study Startup business process artifacts that are not filed into the TMF. It also features templates, lifecycles, and workflows to help you manage startup activities in a complete, efficient manner, and monitor and report on progress and performance.
Vault Study Startup is part of the Vault Clinical Operations family of applications. Within a single Vault, your organization can have one, two, or all of these applications. These applications share a common data model, but each provides additional pieces of functionality to help manage the clinical trial process.
Study Startup Features
Vault Study Startup is built on the Vault platform and therefore has all features that we describe in the platform help topics. In addition, Study Startup provides these capabilities specific to starting a clinical trial:
- Object Configuration: Vault Study Startup shares with other Clinical Operations applications a hierarchical structure of Study, Study Country, and Site objects, as well as related Study Person, Milestone, and Product objects. With the Person, Organization, and Location objects, you can manage those people, places, and organizations, as well as the frequently-reused documents associated with them.
- Template Milestones & Expected Documents: Milestone templates allow users to create study plans that are consistent across trials, and then create milestones, milestone dependencies, and expected documents in bulk for studies, study countries, study sites, study personnel, study organizations, and study products. Creating from a template ensures consistency across studies, as well as compliance with country-specific business practices.
- Country Intelligence: Study startup requires the collection of a variety of key documents, with requirements varying by country. To support this process Vault Study Startup includes a predefined set of Country Intelligence configurations, such as document types, template milestones, dependencies, EDLs, and expected documents that reflect the documents required by country-specific regulatory agencies. Country Intelligence accelerates the configuration of your Vault to better plan and execute global startup activities. Note that this is not an exclusive list of all documents required for applications and submissions. Such applications should be thoroughly reviewed by regulatory specialists for completeness.
- Site Activation Progress View: The critical path for site activation requires collecting site documents quickly, finalizing contracts and budgets, and ensuring local approvals are complete. The Site Activation Progress page presents study startup specialists with a view of overall progress across a study country, including a full list of sites and EDL items, so they can easily identify any blockers to a site’s greenlight. Status indicators and hover cards provide at-a-glance details, and users can navigate directly to documents to remind the site to submit documents or take other actions, enabling you to get every site to first subject, first visit faster.
- Contracts & Budgets Document Lifecycles: A key part of the study startup process is the finalization of contracts and financial terms with participating clinical sites. To support this, Study Startup includes special document types, lifecycles, and workflows for study contracts and budgets. Users can share proposals with sites, review and suggest counterproposals, escalate to contract and legal leads, and manage the entire contracting and budget process in Vault, all while calculating key metrics and cycle times to monitor timeliness and identify areas for improvement.
- Milestone Lifecycle & Workflows: Milestones are a key part of the study startup process, defining the critical path to open a country and greenlight sites. Vault Study Startup includes special lifecycles and workflows to control the process by which users define and update milestone plans, and to calculate key dates and cycle-time metrics to drive retrospective analysis. This includes workflows for submission-related milestones, which incorporate additional layers of review so teams can ensure completeness before they handoff to regulatory groups.
- Site Selection & Feasibility: Before site startup activities begin, sponsors must identify potential clinical sites and qualify that they are suitable for participating in a given study. Study Startup helps startup teams find sites and investigators by supporting the collection of data on experience and equipment. Once site candidates have been identified, workflows within Vault help you manage the selection process and calculate key dates and metrics along the way to identify potential bottlenecks in the process and assist with future planning.
- Managing Unblinded Content: This feature enables Vault admins to define which users can create unblinded (restricted) content related to a study and which can create blinded (unrestricted) content. When users create or classify documents, or update Study, Study Country, or Site document field values, Vault automatically sets the Content (
blinding__v) document field value according to the type of content they can create, allowing organizations to securely and confidently manage restricted content in Vault.
- Study Startup Specialist Homepage: Study Startup Specialists can use this homepage to see actionable views of tasks, milestones, and expected documents at the Study, Study Country, and Site levels. Viewing this information on a single page allows specialists to easily identify overdue and high-priority items.
Learn about using the Vault Study Startup application in these articles:
- Using the Study Startup Specialist Homepage
- Auto-Filing Documents in Binders
- About the Model & Artifact Objects for Study Startup
- Using Site Activation Progress View
- Quality Issues
Learn about configuring the Vault Study Startup application in these articles: